CANTON, Mich. (8/16/2022) – The TOGETHER Trial, which uses an Electronic Data Capture (EDC) system designed, built, and maintained by MMS Holdings, a data-focused contract research organization (CRO), won the Society for Clinical Trial’s annual Trial of the Year Award for 2021.
The David Sackett Trial of the Year Award is given annually to a trial that meets five standards:
- Improves the lot of humankind
- Provides the basis for substantial, beneficial change in health care
- Reflects expertise in subject matter, excellence in methodology and concern for study participants
- Overcame obstacles in implementation
- The presentation of its design, execution and results is a model of clarity and intellectual soundness
The TOGETHER Trial is a partnership formed to find affordable and effective treatments for COVID-19 from existing medications to reduce the pandemic’s serious implications on low and medium-income countries.
The TOGETHER Trial’s EDC system, designed by MMS, shares and compares data from 22 sites to generate statistically meaningful results. The EDC database was built so multiple treatment arms can be added throughout the study lifecycle and can be extracted separately or combined based on analysis requirements.
“COVID-19 was a global game changer on many fronts, and MMS adapted with our SOUL (Sense of Urgency and Leadership). Our goal was to ensure our global community had access to effective COVID-19 therapies,” says Dr. Uma Sharma, Chief Executive Officer, MMS. “We are proud that our data management skills and scientific expertise are at the forefront, helping discover and make available therapies that will positively impact lives worldwide.”
Due to the urgent need to enroll patients, MMS designed and implemented the EDC in less than two weeks.
“It was important for us to get the EDC up as quickly as possible so we could begin finding treatments,” says Doreen Van Huyssteen, Associate Director of Clinical Data Management, MMS. “It is a testament to the skills of our global teams that we were able to get the EDC up in two weeks, a timeline unheard of in our industry. In addition, the complexity of the study design increased by 353% over the life of the study so far, another testament of achievement in successfully designing and executing complex databases.”
The EDC has had an unheard-of 23 post-go-live changes, more than 800,000 pages, 5.5 million data points, and over 800,000 queries managed by the MMS data management team.
The study is ongoing and continues to grow in complexity as one would expect with Covid-19. In addition, MMS is in the process of adding additional functionality to the EDC to improve efficiencies.
MMS Holdings (MMS) is an innovative, data-focused CRO that supports the pharmaceutical and biotech industries with a proven, scientific approach to complex trial data and regulatory submission challenges. Strong industry experience, technology-enabled services, and a data-driven approach to drug development make MMS a valuable CRO partner, creating compelling submissions that meet rigorous regulatory standards. With a global footprint across four continents, MMS maintains a 97 percent customer satisfaction rating. Visit mmsholdings.com to learn more.